Valneva SE (NASDAQ: VALN) announced that the European Medicines Agency (EMA) has approved Valneva's inactivated, whole-virus COVID-19 vaccine candidate, VLA2001, for marketing authorization. With the acceptance of the MAA, VLA2001 moves from the rolling review procedure to the official evaluation process by the European Medicines Agency's Committee for Human Medicinal Products (CHMP).
The EMA's acceptance of VLA2001's application is a significant step toward product approval. Valneva is completely committed to collaborating with regulators, European member states, and the European Commission to make a more traditional and well-established COVID-19 vaccine technology available to Europeans.
Furthermore, Valneva expects to receive a good CHMP opinion in June 2022 if the CHMP accepts the company's conditional marketing authorization application. The European Commission (EC) will study the recommendation and make a final decision on the MAA if the CHMP gives a good assessment. The centralized marketing license would be effective in all European Union Member States, as well as Iceland, Liechtenstein, and Norway if approved by the European Commission.
The European Commission (EC) had previously informed Valneva that it intended to terminate the advance purchase agreement (APA) for Valneva's inactivated whole-virus COVID-19 vaccine candidate VLA2001. If VLA2001 does not get a marketing license from the EMA before April 30, 2022, the EC has the power to cancel the APA. Valneva has 30 days from May 13, 2022, to get a marketing authorization or provide an appropriate repair plan under the conditions of the APA.